Core Viewpoint - The article discusses the extension of centralized procurement to biosimilars in China, highlighting the implications for market dynamics and pricing strategies in the pharmaceutical industry [4][6]. Group 1: Centralized Procurement of Biosimilars - The Anhui Provincial Medical Procurement Platform has initiated information reporting for eight monoclonal antibody products, marking the beginning of centralized procurement for biosimilars [4]. - Biosimilars are large molecule biological products that are similar in quality, safety, and efficacy to already approved reference drugs, and their development is typically more costly and time-consuming than small molecule drugs [4][8]. - The centralized procurement process for biosimilars is expected to take longer than previous chemical drug procurements due to the need for comprehensive data collection and rule formulation [6]. Group 2: Market Impact and Dynamics - The total sales of the eight involved biosimilar products are projected to approach 30 billion yuan in 2024, with specific products like Bevacizumab exceeding 10 billion yuan in sales [9]. - The article emphasizes that the centralized procurement of biosimilars will not drastically disrupt existing market structures but will lead to adjustments within the current competitive landscape [9][10]. - The involvement of multiple companies in the production of these biosimilars indicates a competitive environment, with several products having three or more approved manufacturers [8][9]. Group 3: Characteristics of Biosimilar Procurement - Compared to chemical drug procurement, biosimilar procurement is characterized by smaller price reductions, comprehensive reporting requirements, and a focus on high-quality products [13][14]. - The procurement process aims to clarify market demand and supply, allowing companies to better predict future business conditions and adjust their product pipelines accordingly [6][10]. - The article suggests that the pricing adjustments in biosimilar procurement will be more moderate than those seen in previous chemical drug procurements, reflecting the unique nature of biological products [14][15].

Core Viewpoint - The Anhui Provincial Medical Price and Centralized Procurement Center has initiated information collection for eight monoclonal antibody biological agents, indicating the commencement of a national centralized procurement alliance for biological drugs in China [1][5]. Group 1: Market Overview - The eight biological drugs targeted for information collection have a combined market sales exceeding 28 billion yuan [2]. - The original manufacturers of these drugs include AbbVie, Amgen, and Johnson & Johnson, with Roche holding the original drugs for several others [2]. - The competitive landscape is intense, particularly for Bevacizumab, which has 13 approved products in the domestic market, with sales reaching 10.576 billion yuan in 2023 [2]. Group 2: Sales Trends - Sales of Adalimumab in sample hospitals increased from 1.257 billion yuan in 2022 to 1.488 billion yuan in 2024, while sales in urban pharmacies rose from 743 million yuan to 931 million yuan [3]. - The market share of original drugs is declining due to the introduction of biosimilars, with the original Adalimumab being surpassed in market share by a biosimilar in 2023 [3]. Group 3: Impact of Centralized Procurement - Centralized procurement is expected to intensify market competition, leading to a redistribution of market shares, with original drugs facing greater pressure from price competition [3][7]. - The procurement process is anticipated to enhance drug accessibility for patients, potentially lowering prices and ensuring quality [4]. - Companies must improve production capacity and flexibility to meet the demands of centralized procurement [4]. Group 4: Regulatory Environment - The development of biosimilars in China has accelerated, with a record 104 registration applications for therapeutic biological products submitted in 2024 [5]. - The centralized procurement of biological drugs is not prohibited, and the National Healthcare Security Administration has indicated that it will consider various factors before implementing such measures [5][6]. Group 5: Future Industry Trends - The initiation of national centralized procurement for biological drugs may shorten the profit period for low-quality products, prompting companies to focus on enhancing product quality and R&D capabilities [7]. - Companies may also shift their R&D focus towards more valuable innovative fields and increase investments in overseas markets to mitigate the impact of localized procurement [7].

Core Insights - The autoimmune disease treatment market is the second largest pharmaceutical market globally, with significant growth potential in China [1][2] - The global autoimmune market reached $132.3 billion in 2022 and is expected to grow to $176.7 billion by 2030, with a compound annual growth rate (CAGR) of 3.68% from 2022 to 2030 [1] - China's autoimmune market is only 8% of its oncology market, indicating substantial room for growth compared to the global ratio of 64.5% [1] Group 1: Market Overview - The autoimmune disease market is the second largest after oncology, with a global market size of $132.3 billion in 2022 [1] - The market is projected to grow to $176.7 billion by 2030, reflecting a CAGR of 3.68% [1] - In China, the autoimmune market was valued at $2.9 billion in 2022, significantly lower than the oncology market at $34.7 billion [1] Group 2: Drug Development - The autoimmune sector has seen the emergence of several blockbuster monoclonal antibody drugs [2] - Three monoclonal antibodies are expected to be among the top 10 global drug sales in 2024, each exceeding $10 billion in sales [2] - These include Dupilumab by Sanofi/Regeneron, Risankizumab by AbbVie/BI, and Ustekinumab by Johnson & Johnson [2] Group 3: Disease Complexity - There are approximately 150 known autoimmune diseases, which can be categorized into systemic and organ-specific autoimmune diseases [3] - A study published in 2023 indicated a prevalence rate of about 10% for autoimmune diseases among a cohort of 22 million individuals in the UK, with 63.9% of new cases being female [3] - Autoimmune diseases exhibit seasonal and regional variations in prevalence [3]

Core Viewpoint - The article discusses the rise of monoclonal antibody (mAb) injections, also known as "biological agents," in the treatment of chronic diseases, highlighting the issues surrounding their online sale and the importance of proper medical supervision for their use [1][11]. Group 1: Market Trends - Monoclonal antibodies are becoming mainstream treatments for chronic diseases such as autoimmune disorders and skin diseases due to the expansion of indications and domestic production [1][11]. - The demand for effective treatments in rheumatology and dermatology is increasing, with mAbs being recognized for their significant therapeutic effects [11][12]. Group 2: Online Sales and Regulations - Some pharmaceutical e-commerce platforms are attempting to sell injectable mAbs online, despite regulations prohibiting the online retail of such prescription drugs [2][6]. - Many sellers use terms like "appointment for medication" and "contact customer service after payment" to imply that they are not directly selling the drugs online, which raises compliance concerns [3][6]. Group 3: Safety and Usage - The use of biological agents requires strict adherence to indications and contraindications, necessitating a doctor's assessment and prescription before use [1][5][8]. - Proper cold chain logistics are essential for the safe transport of these drugs, but safety also depends on medical supervision and monitoring during treatment [8][10]. Group 4: Efficacy and Limitations - Biological agents have shown remarkable efficacy in treating various autoimmune diseases, but they are not a cure and require ongoing management [12][13]. - The high cost of mAbs, often thousands of yuan per injection, poses a barrier to access, and their effectiveness can vary among patients [13].

Group 1 - The company achieved profitability in 2024 with a revenue of approximately 1.407 billion yuan (+11.75%), driven by a significant increase in overseas income, which reached about 225 million yuan (+62.07%) [1] - The company reported a net profit attributable to shareholders of approximately 31 million yuan in 2024, recovering from a loss of about 190 million yuan in 2023 [1] - In Q1 2025, the company generated revenue of approximately 354 million yuan (-1.97%), with a net profit attributable to shareholders of about 26 million yuan (+106.21%) [1] Group 2 - The rapid growth of overseas revenue is highlighted, with a year-on-year increase of 84.33% in Q1 2025, following the successful sales of albumin paclitaxel in the EU [2] - The company has covered all emerging market countries with populations over 100 million and GDPs in the top thirty, indicating a strong market presence [2] - By the end of 2024, the company had introduced 16 products and submitted over 120 registration applications in more than 60 countries, with several products expected to be approved for sale in 2025 [2] Group 3 - The company has established five leading technology platforms for drug development, including recombinant protein drugs and antibody drugs, with two assets in Phase III clinical trials [3] - The company has received clinical approval in the US for its inhaled human interferon α1b solution, indicating progress in its innovative drug pipeline [3] Group 4 - The company is expected to see revenue growth from 1.781 billion yuan in 2025 to 2.495 billion yuan in 2027, with net profits projected to increase from 106 million yuan to 253 million yuan during the same period [4] - The current market valuation corresponds to a PE ratio of 72.24X for 2025, 41.80X for 2026, and 30.14X for 2027, suggesting a favorable investment opportunity [4]

Investment Rating - The report maintains a "Buy" investment rating for the company, indicating a positive outlook for future performance [10]. Core Views - The company has shown significant improvement in financial performance, achieving a revenue of 1.407 billion yuan in 2024, a year-on-year increase of 11.75%, and a net profit of 31 million yuan, up 116.54% year-on-year [6]. - The first quarter of 2025 saw a revenue of 354 million yuan, a slight decrease of 1.97% year-on-year, but net profit increased by 106.21% to 26 million yuan, indicating strong profitability despite revenue fluctuations [6]. - The company is actively expanding its international presence, particularly in the EU, with overseas sales revenue reaching approximately 224.37 million yuan, a year-on-year growth of about 61.96% [7]. - The integration of AI in drug development is enhancing the efficiency and quality of new drug research, with several innovative projects underway [8]. Financial Performance Summary - In 2024, the company achieved a gross margin of 68.69%, which slightly decreased by 2.10 percentage points year-on-year, while the expense ratio improved significantly by 28.13% to 63.37% [6]. - The projected revenues for 2025, 2026, and 2027 are 1.884 billion yuan, 2.298 billion yuan, and 2.700 billion yuan, respectively, with expected year-on-year growth rates of 33.9%, 22.0%, and 17.5% [11]. - The net profit forecast for the same years is 141 million yuan, 207 million yuan, and 338 million yuan, reflecting substantial growth rates of 347.1%, 47.2%, and 62.9% [11]. Strategic Initiatives - The company is focusing on enhancing its international marketing structure and expanding its product offerings in key disease areas, which is expected to bolster its market position [7]. - The company has received GMP certification and market approval for its paclitaxel product in the EU, marking a significant milestone in its international expansion efforts [7]. - Ongoing collaborations and innovative drug development projects are expected to yield new therapeutic options, particularly in oncology and autoimmune diseases [8][9].

医药 2025 年 04 月 14 日 科兴制药(688136.SH) 24年利润端实现扭亏，关注新品海外放量节奏 推荐（维持） 股价：30.00 元 主要数据 | 行业 | 医药 | | --- | --- | | 公司网址 | www.kexing.com | | 大股东/持股 | 深圳科益医药控股有限公司/66.01% | | 实际控制人 | 邓学勤 | | 总股本(百万股) | 200 | | 流通 A 股(百万股) | 200 | | 流通 B/H 股(百万股) | | | 总市值（亿元） | 60 | | 流通 A 股市值(亿元) | 60 | | 每股净资产(元) | 8.19 | | 资产负债率(%) | 48.2 | | 行情走势图 | | 相关研究报告 【平安证券】科兴制药（688136.SH ）*公司动态跟踪 报告*出海业务有望保持高增长，创新药平台价值静待 重估*推荐20250402 证券分析师 | 叶寅 | 投资咨询资格编号 | | --- | --- | | | S1060514100001 | | | BOT335 | | | YEYIN757@pingan.com.cn | | ...